Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization Units (TROMBODOM/ADOMFIB Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,953
- 试验地点
- 1
- 主要终点
- Incidence of thrombotic events
研究概览
简要总结
The thromboembolic disease is a common complication of patients admitted to conventional hospitalization units. To prevent such complications, thromboprophylaxis is indicated in high-risk patients identified with validated risk-assessment models such as Padua score and IMPROVE-VTE score. However, the relation between thromboembolic disease and inpatients is yet to be demonstrated in new clinical settings such as at home hospitalization units. Moreover, patient immobilization is key in the pathogenesis of thromboembolic complications: therefore, it is crucial to collect raw data of patient mobility during admission.
The goal of this observational study is to compare the thromboembolic risk of patients admitted with acute medical diseases to at home hospitalization units with conventional hospitalization units.
The main questions it aims to answer are:
- Is the estimated thromboembolic risk of patients admitted with acute medical diseases to at home hospitalization units similar to those admitted to conventional hospitalization units?
- Are the risk-assessment models used to predict thromboembolic risk of patients admitted with acute medical diseases to conventional hospitalization units (Padua and IMPROVE-VTE score) valid in at home hospitalization patients?
Participants admitted with acute medical diseases to either a conventional hospitalization unit or at home hospitalization units will be included in a prospective registry in order to investigate the 90 days incidence of thromboembolic disease. A cohort of such patients will be controlled with triaxial accelerometer in order to collect raw data regarding patient mobility during admission.
详细描述
1953 patients will be recruited (1700 in at home hospitalization units and 253 in conventional hospitalization units). All patients must accept and sign the informed consent. After being admitted to the study, patients will be included in the prospective registry with baseline evaluation of basic clinical data, including risk-assessment models (Padua and IMPROVE-VTE scores), examination, ECG, self-assessed mobility, and biochemistry markers. Triaxial accelerometers will also record mobility and sleep time of 135 patients from conventional hospitalization units and 135 patients from at home hospitalization units, from which physical activity questionnaires (International Physical Activity Questionnaire (IPAQ), The Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)), handgrip strength, 30-second sit-to-stand test, the Short Physical Performance Battery (SPPB), the Spanish Version of 5-level European Quality of Life-5 Dimensions (5-level EQ-5D), Fried frailty criteria and Lobo's cognitive mini-examination will also be obtained. All 1953 patients will be followed for 90 days after discharge to assess thromboembolic disease incidence (pulmonary embolism, deep venous thrombosis, and atrial fibrillation), major and clinically relevant non-major bleedings (according to International Society on Thrombosis and Haemostasis Standards) and death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients admitted with acute medical diseases to either a conventional hospitalization unit or at home hospitalization units
- •Capable and willing to provide an informed consent
排除标准
- •End of life disease, palliative care or with an expected survival inferior to 3 months
- •Patients receiving therapeutic doses of any anticoagulant drug
- •Active diagnosis of thromboembolic disease
- •Prior diagnosis of atrial fibrillation
- •Pregnancy or breast-feeding.
- •SARS-CoV-2 diagnosed using real-time reverse transcriptase polymerase chain reaction (PCR) tests or positive for SARS-CoV-2 virus antigen <90 days before randomization.
结局指标
主要结局
Incidence of thrombotic events
时间窗: Within 3 months after hospitalization
Incidence of thrombotic events (deep venous thrombosis and pulmonary embolism) of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units
Estimated hemorrhagic risk at admission
时间窗: Within 3 months after hospitalization
Estimated hemorrhagic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with IMPROVE-Bleeding score (high or low risk). "IMPROVE-Bleeding" score is a risk assessment model that scores from 0 to 33, with a score of 7 or higher identifying patients at "high risk" of hemorrhagic events.
Accelerometry
时间窗: The duration of the hospitalization, from 0,9 days to 9 days
A GENEActiv watch will be used on left wrist at a sampling rate of 85,70 Hz to measure movement in the x, y, and z direction. The results will be the duration of sleep, the time spent in sedentary attitudes and the amount of light, moderate and vigorous physical activity. All the outcomes may range from 1 to 1440 minutes per day.
Estimated thrombotic risk at admission measured with Padua score
时间窗: Within 3 months after hospitalization
Estimated thrombotic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with Padua score (high or low risk). "Padua" score is a risk assessment model that scores from 0 to 20, with a score of 4 or higher identifying patients at "high risk" of thromboembolic disease.
Incidence of atrial fibrillation diagnosis
时间窗: Within 3 months after hospitalization
Incidence of atrial fibrillation diagnosis in patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units
Estimated thrombotic risk at admission measured with IMPROVE-VTE score
时间窗: Within 3 months after hospitalization
Estimated thrombotic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with IMPROVE-VTE score (high or low risk). "IMPROVE-VTE" score is a risk assessment model that scores from 0 to 12, with a score of 2 or higher identifying patients at "high risk" of thromboembolic disease.
次要结局
- The Spanish Version of 5-level European Quality of Life-5 Dimensions (5-level EQ-5D)(First day of hospitalization (baseline))
- The Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)(First day of hospitalization and 3 months after hospitalization)
- Prevalence of pharmacological thromboprophylaxis use(Last day of hospitalization (up to 9 days))
- Prevalence of correct pharmacological thromboprophylaxis use according to objective mobility evaluation with accelerometry(Last day of hospitalization (up to 9 days))
- Concordance of self-perceived immobilization and objective accelerometry measurements of physical activity for reduced mobility identification(At admission and during the duration of the hospitalization, from 0,9 days to 9 days)
- Prevalence of reduced mobility, measured with self-perceived immobilization(Baseline)
- Prevalence of reduced mobility, measured with accelerometry(The duration of the hospitalization, from 0,9 days to 9 days)
- International Physical Activity Questionnaire (IPAQ)(First day of hospitalization and 3 months after hospitalization)
- Handgrip strength(First (baseline) and last day of hospitalization (up to 9 days))
- 30-second sit-to-stand test(First (baseline) and last day of hospitalization (up to 9 days))
- The Short Physical Performance Battery (SPPB)(First (baseline) and last day of hospitalization (up to 9 days))
- Fried frailty criteria(First day of hospitalization (baseline))
- Lobo's cognitive mini-examination(First day of hospitalization (baseline))
- Prevalence of correct pharmacological thromboprophylaxis use according to risk assessment models(Last day of hospitalization (up to 9 days))